FIAX TOXO-M ANTIBODIES TEST KIT

FIAX TOXO-M ANTIBODIES TEST KIT is an FDA 510(k)-cleared medical device (K850591) manufactured by Intl. Diagnostic Technology. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 29, 1985. Regulation: 8.